MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN DEPUY ASR ACETABULAR CUP; HIP ACETABULAR CUP

Catalog Number UNK-HIP

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510# number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2017: medical records and implant photos received.Update (b)(6) 2017: translated litigation and medical records received.Litigation alleges inflammation, elevated metal ions, unexplained fever, pain, ambulation difficulties, squeaking/grinding sound, metallosis and granuloma.After review of medical records for mdr reportability, it was reported that the patient was revised to address metallosis with progressive pain and very high values of cobalt at almost 40 x the normal amount.Revision notes reported small dark effusion, immense quantity of black tissue like carbon, cone of the stem is fully oxidized, metallosis, and granuloma.Medical reports indicate bursitis, hypersensitivity to metal, armd/altr, synovitis, effusion in the bursa of the psoas.Part and lot numbers are unknown.This complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY ASR ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7164773
• MDR Text Key: 96386179
• Report Number: 1818910-2018-10016
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR